BEUDAMED
    FDA Adverse Event Other Summary report: N

    RUBBER DAM 5X5 GREEN

    MDR report key: 119472 · Received September 11, 1997

    Report

    Report Number
    2411236-1997-01106
    Event Type
    Other
    Date Received
    September 11, 1997
    Date of Event
    July 17, 1997
    Report Date
    July 28, 1997
    Manufacturer
    COLTENE/WHALEDENT, INC.
    Product Code
    EIE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PT RUSHED TO THE HOSPITAL 45 MINUTES AFTER INJECTION. RUBBER STEM SEATED, SO IT'S QUESTIONABLE AS TO WHAT THE PT IS ALLERGIC TO. PT IS GOING TO SEE AN ALLERGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUBBER DAM 5X5 GREEN PROTECTIVE BARRIER EIE COLTENE/WHALEDENT, INC. 08561 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other